EUCTR2014-005133-30-Outside-EU/EEA进行中（未招募）不适用
A Phase 3b, Open-Label, Controlled, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine.
ovartis Vaccines & Diagnostics, Inc.0 个研究点目标入组 500 人开始时间: 2014年12月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Children eligible to be enrolled in the study are those whose parents provide written informed consent, and are in generally good health based on the clinical judgment of the investigators.
- •Group 1 and 2 (Follow up) subjects must be 40 +/- 3 months of age at the time of enrollment and participated in the original V59P14 study.
- •Group 3 and 4 (Naïve) subjects must be healthy, meningococcal vaccine-naïve children ages 40 +/- 3 months (Group 3) or 60 +/-3 months (Group 4) at the time of enrollment, respectively.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 500
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Serious acute, or chronic illnesses are reasons for exclusion.
- •Subjects who have received any vaccine (excluding influenza vaccines) 28 days preceding enrollment visit. Influenza vaccines (including FluMist®) are excluded for the 14 days prior to the enrollment visit.
- •Subjects who have received any meningococcal vaccine since birth (Groups 3 & 4 -naive) or last study dose in V59P14 trial (Groups 1 & 2 - follow on).
研究者
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